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1 November 2013 Edition Vol. 7, Issue 10 The Evolving Landscape of Payment Care Delivery and Manufacturer Implications of Coverage Expansion By Gordon Gochenauer, Director, Oncology Commercial Strategies, Kantar Health The U.S. continues to grapple with healthcare costs that consume an ever-increasing proportion of gross domestic product (GDP) but does not translate into a relatively better national health status than countries that spend much less on healthcare. This spending growth is unsustainable for the public and private sectors, a view that has become more pronounced during the recent economic recession and growing government deficits. The Patient Protection and Affordable Care Act (PPACA) of 2010 established a framework for reorganization of the U.S. healthcare delivery system with several key initiatives: Payment and Care Delivery: Accountable care organizations (ACOs) continue to form, further enabling the expansion of clinical pathways. Coverage Expansion: State health insurance exchanges are likely to increase cost sensitivity, affecting prescribing attrition and abandonment. Medicaid may become a more important player in oncology. Insurance Regulation and Affordability: Elimination of annual and lifetime limits will assist patients financially, but affordability challenges remain, especially for oral cancer drugs. Quality and Health Information Technology (HIT) Initiatives: Growing adoption of electronic medical records (EMRs) enable development of ACO models and pathway implementation. Data will slowly become available to inform evidence-based medicine. Community Practices ACOs are intended to bring physicians into an integrated system that shares the rewards of efficient, coordinated patient care. Continued inadequate reimbursement from payers, both public and private, has increased the attractiveness of participation in novel delivery and reimbursement arrangements for community oncology practices. In a 2013 Kantar Health oncologist survey, respondents cite a strategic desire to provide the community with coordinated, integrated care as the primary driver of hospital affiliation, unlike the practical goals (financial survival and business efficiency) that drove affiliations up through Practice and hospital participation in novel reimbursement mechanisms, particularly ACOs and enhanced reimbursement for the use of pathways, is growing. According to Kantar Health s oncologist and practice manager surveys, ACOs are the fastest growing novel reimbursement arrangement with 30% of practices participating, covering 10% of all cancer patients. Participation is expected to grow to 50% within the next one or two years as practices and hospitals experiment with value-based reimbursement and coordinated care. Pathways are currently the most common novel reimbursement mechanism in community oncology practices, with 43% of practice managers reporting their use, covering 11% of their patients; both hospitals and practices expect involvement to grow in the future, according to Kantar Health s surveys. Cancers most commonly affected by pathways include colorectal, breast, non-small cell lung (NSCLC) and prostate cancer, although some programs include a wider array of cancers, including non-hodgkin s lymphoma, multiple myeloma, renal cell carcinoma and melanoma. Some payers believe that including only the top four or five cancers in pathway programs is sufficient to restrain drug expenditure growth. One important key of ACO initiatives is that the expansion of health information technology (HIT) allows pathway programs and other initiatives to combine management of oral and physician-administered injectables across a patient s pharmacy and medical benefit, thereby crossing a line once perceived as insurmountable to manage across a patient s continuum of oncology drug utilization. Patient Out-of-Pocket Cost While expanded insurance coverage as a result of the ACA is helping patients gain access to healthcare, challenges to affordability are likely to remain. OOP costs are not necessarily alleviated as a part of the ACA, particularly for commercial plans, as these costs continue to trend upward. Kantar Health s 2013 Managed Care Organization (MCO) survey showed that nearly 30% of the commercial lives managed by the surveyed MCOs do not have an annual out of pocket (OOP) maximum for drugs covered under the medical benefit. Without an OOP limit in place, patients may experience financial hardship especially cancer patients who generally have a higher rate of financial need. Additionally, high-deductible health plans (HDHPs) are appealing to payers and employers since greater patient exposure to cost through high deductibles presumably lowers expenditures on nonessential care. Studies have shown patients in these types of plans are healthier 1 ; and may be less at risk for certain types of cancer. Although the percentage of patients enrolled in HDHPs has increased 30% annually from 2006 to 2012, enrollment was similar in 2013 as in 2012 (20% vs. 19%), it is important to note that enrollment patterns vary by firm size. Workers in large firms (200 or more workers) are more likely than workers in small firms (3-199 workers) to enroll in preferred provider organizations (PPOs; 62% vs. 47%). Workers in small firms are more likely than workers in large firms to enroll in point-of-service (POS) plans (16% vs. 5%).

2 For many commercial plans, oral cancer drugs are managed and placed on specialty tiers, which are traditionally Tier 4 or higher. The specialty tiers decrease the patient s ability to afford treatment, as an average co-pay of $79 is 172% higher than the most common tier (Tier 2) for commercial payers. Cancer patients can be on multiple drugs, for numerous conditions, resulting in significant OOP costs.

3 As state health insurance exchanges become available in 2014, they are fortunately expected to limit OOP costs, although costs will remain significant and patients will continue to need financial assistance. OOP costs are expected to vary for the newly insured, adding to the complexity of their benefit design. Such costs have not been incurred in the past and will pose new hurdles to the affordability of healthcare. The underinsured and low- to moderate-income populations covered by the state exchanges are most likely to be affected, as OOP costs may range from slightly less than $2,000 to approximately $6,000 per year. Recent estimates 2 by Kaiser Family Foundation indicate deductibles in bronze and silver plans would be high enough to qualify as HDHPs and could be paired with a health savings account. These types of plans may lead to patients having difficulties in affording cancer care. Accordingly, as patients will have varying levels of coverage, manufacturer assistance will need to extend to those identified beneficiaries within the exchanges. As healthcare reform evolves, HDHPs may continue to increase in plan share, as employer groups look to reduce costs and shift more of the liability to employees. Additionally, the health exchanges in the case of bronze and silver plans will likely resemble HDHPs. Manufacturer Implications of Coverage Expansion Changes to Cancer Payer Mix Due to Coverage Expansion Manufacturers will need to monitor payer mix in light of coverage expansion under the ACA with the state exchanges and the expansion of Medicaid. Commercially insured and uninsured patients are eligible for manufacturer-designed patient assistance programs (PAP), whereas all patients are eligible for assistance from charitable foundations. Foundations represent the only option for Medicare patients. Understanding the simple breakdown between these groups is important, as is understanding the co-pay levels for those with prescription drug co-pays or coinsurance. This information can inform how to design a PAP and what charitable foundation contributions to make. Figure 3 projects that change in payer mix for the U.S. population through 2021.

4 A basic understanding of OOP costs for patient therapy starts at understanding the percentage of patients too young to receive Medicare and those who are eligible to receive Medicare. It is also important to realize that the drug-treated populations of most cancers will be of different age mixes than the incident or prevalent populations; thus these populations each will have a different payer mix. On top of that, the mix of drug-treated patients will have varying levels of pharmacy benefit (coverage for oral therapies and other self-administered drugs) versus medical benefit (coverage for physician-administered drugs mainly including intravenous oncology therapies). For example, understanding the percentage of commercially insured patients with a coinsurance rather than co-pay for oral therapies is important as patient cost-shifting is increasing. Cancer is generally considered a disease of the elderly, with Medicare as the primary payer; however, certain cancers can have an equivalent mix or more commercially insured patients. For example, Medicare is the predominant payer for NSCLC. In contrast, chronic myelogenous leukemia has a nearly equal mix of commercial and Medicare lives.

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6 Historically, Medicaid has not been a major component of cancer payer mix with the majority of the Medicaid being a pediatric population. However, the expansion of Medicaid under ACA will likely result in more adults being covered by this payer. Additionally, the Department of Health and Human Services just announced that the state health insurance exchanges will not be subject to regulations similarly to Medicare. The crux is that patients who purchase policies through the exchanges will be eligible for manufacturerdesigned PAPs. 340B Enrollment Hospitals that qualify as 340B institutions (as Disproportionate Share Hospitals) based on the treatment of Medicaid (or other low-income patients) have enjoyed discounts of 21-50% on outpatient drugs for several years. 340B participation has been growing for hospitals and the practices affiliated with them, but as Medicaid expands in 2014, even more entities will be 340B eligible. Institutions in states that opt in for Medicaid expansion will become more likely to exceed the 11.75% disproportionate share threshold required to access 340B drug discounts. Since the end of 2009, 1,588 institutions have become active in the 340B program. Since the end of 2011, 3,423 hospital sites joined with the addition of only six hospital entities due to many systems adding more satellite and affiliated sites into the 340B program. With Medicaid expansion, it is estimated 1,500 more institutions may be newly eligible. This is important as exhibited by Genentech. Genentech s 340B drug discounts totaled $1 billion in 2012 and are growing at 20% to 25% a year, impacting product pricing and causing the company to establish a 340B integrity program to ensure recipients of the discounts are complying with legal requirements.

7 Profit from 340B participation funds non-billable services and physician employment, but at the expense of manufacturer revenue. A lack of definition of the 340B patient results in the use of these discounted drugs for insured patients, which are then billed for full reimbursement from the insurer. The 340B program has resulted in a competitive disadvantage for non-340b providers, such as independent community oncology practices. Formulary Inclusion in the Exchanges A key concern for manufacturers is which agents are included in formularies among plans offered through the exchanges. Exchange plans need to include only one benchmark option. While formulary exclusion has been a touchy topic in oncology in the past, there are signs that certain oncology agents and other specialty agents may not be included in all plan formularies, particularly the bronze and silver plans. Manufacturers will need to develop and continuously reevaluate product value propositions of their drugs to ensure formulary inclusion and for pathway inclusion by payer and provider decision makers. As oncology participation in ACOs grows, manufacturers will also need to place greater emphasis on patient experience, quality and care coordination. Additionally, the evolution coverage expansion will alter the payer mix within a cancer thus will have a direct effect of the affordability of cancer care. About Kantar Health Gordon Gochenauer is a Director, Commercial Planning at Kantar Health. Kantar Health is a leading global healthcare advisory firm and trusted advisor to the world s largest pharmaceutical, biotech, and medical device and diagnostic companies. It combines evidence-based research capabilities with deep scientific, therapeutic and clinical knowledge, commercial development know-how, and marketing expertise to help clients launch products and differentiate their brands in the marketplace. Kantar Health s oncology-related offers include Oncology Market Access US (OMA US), which provides strategic and tactical insights into the evolving oncology landscape. Combining Kantar Health s commercial and clinical expertise in oncology, OMA US provides cutting-edge information and analysis on critical reimbursement, coverage and competitive issues in the US oncology marketplace. If you would like us to act as catalysts for you, contact us at

8 Resources: 1. ERBI Characteristics of the CDHP Population, Caribou Publishing. All rights reserved. Reproduction in whole or in part is prohibited.

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